Normal Serum Adiponectin Levels in Females

March 30, 2007 updated by: The Cooper Health System

Normal Serum Adiponectin Levels in Females During the Childbearing Ages and Normal Serum Adiponectin Levels in Pregnancy

The purpose of the study is to establish the normal levels of the hormone adiponectin in women. Adiponectin is a newly discovered hormone, which is said to be associated with many changes in the human body and metabolism. The researchers aim is to establish the normal levels of this hormone. Hence, the researchers can identify people with abnormal levels who may be at risk of diseases and can do more studies to help them.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prevalence of obesity has increased dramatically in recent years . It is commonly associated with type 2 diabetes, coronary artery disease, and hypertension, and the coexistence of these diseases has been termed the metabolic syndrome. White Adipose Tissue (WAT) has been increasingly recognized as an important endocrine organ that secretes a number of biologically active "adipokines" . Of these adipokines, adiponectin has recently attracted much attention because of its antidiabetic and antiatherogenic effects and is expected to be a novel therapeutic tool for diabetes and the metabolic syndrome . Adiponectin directly regulates glucose metabolism and insulin sensitivity by activation of AMPK.

Adiponectin expression is reduced in obese, insulin-resistant rodent models. Plasma adiponectin levels are also decreased in an obese rhesus monkey model that frequently develops type 2 diabetes. Levels have also been reported to be reduced in obese humans, particularly those with visceral obesity, and to correlate inversely with insulin resistance. Prospective and longitudinal studies have shown that lower adiponectin levels are associated with a higher incidence of diabetes.

Hypoadiponectinemia has been demonstrated to be independently associated with the metabolic syndrome. Reduced plasma adiponectin levels are also commonly observed in a variety of states frequently associated with insulin resistance, such as cardiovascular disease, ischemic heart disease, and hypertension. In women, lower adiponectin levels were associated with breast cancer, endometrial cancer, and polycystic ovarian syndrome.

By establishing normal serum levels of Adiponectin, researchers will be able to demonstrate deviations from the norm associated with investigated diseases and variables. When applied to pregnancy, it will help identify obstetrical complications associated with abnormal levels.

Study Type

Interventional

Enrollment

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age: 15 - 40 years old.
  2. BMI: 18.5 - 24.9
  3. No medical or chronic health problems.
  4. If pregnant, singleton.
  5. First blood sample can be obtained before 13 weeks gestation.
  6. Plans to continue pregnancy till term and deliver at our hospital

Exclusion Criteria:

  1. Hypertension.
  2. Diabetes Mellitus.
  3. Ischemic heart disease.
  4. Metabolic disorders e.g. hyperlipidemia, hypercholesterolemia.
  5. Endocrinological diseases e.g. thyroid or adrenal diseases.
  6. Chronic Debilitating diseases e.g. SLE, or Cancer.
  7. BMI less than18.5 or greater than 25.
  8. Anorexia or Bulimia.
  9. Polycystic ovarian disease.

  10. In pregnant group:

    1. Multiple gestations.
    2. Hyperemesis or dehydration.
    3. History of Gestational Diabetes, Preeclampsia, or other complications with previous pregnancies
    4. If abnormal weight gain during pregnancy, will continue in the study but would not be included in establishing normal levels.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cooper Health System

Investigators

  • Principal Investigator: Hazem Elshoreya, MD, The Cooper Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Anticipated)

June 1, 2007

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 30, 2007

First Posted (Estimate)

April 2, 2007

Study Record Updates

Last Update Posted (Estimate)

April 2, 2007

Last Update Submitted That Met QC Criteria

March 30, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06041EX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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